Medical article with rotatable wings

ABSTRACT

A medical device assembly includes a catheter with a catheter hub, a housing, a first wing, and a second wing. The housing surrounds the catheter hub, but is spaced from the catheter hub to define a channel. The first wing includes a first hook disposed in the channel to permit rotation of the first wing about the catheter hub. The second wing includes a second hook disposed in the channel to permit rotation of the second wing about the catheter hub.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/577,425, filed Sep. 17, 2012, now U.S. Pat. No. 9,700,000, which is aNational Stage of International Patent Application No.PCT/US2011/026897, filed Mar. 2, 2011, titled “MEDICAL ARTICLE WITHROTATABLE WINGS,” which claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Application No. 61/310,223, filed Mar. 3, 2010, titled“MEDICAL ARTICLE WITH ROTATABLE WINGS,” each of which is herebyincorporated by reference in its entirety into this application.

BACKGROUND 1. Field of the Invention

This invention relates to a medical article used to provide access tothe vasculature of a patient. More particularly, this invention relatesto a medical article With Wings configured to stabilize the medicalarticle on the patient.

2. Description of the Related Art

Medical professionals routinely require access to the vasculature of apatient for delivery or Withdrawal of fluids to or from the patient'sbloodstream. When such access is required over any period of time, it iscommon to introduce a catheter or similar medical article into thebloodstream of the patient to provide reusable access, for instance inorder to deliver medication and/or fluids directly into the bloodstreamof the patient.

In intravenous applications, the catheter is generally short andincludes a fitting, for example, a luer connector, at one end that isdesigned for attachment to another medical line or another medicalarticle. Such a connector may also include a spin nut to lock themedical line to the catheter. In this way the same catheter may beconnected to and released from different medical lines in order toexchange the medical lines without the need to introduce multipleintravenous catheters. In some cases, an extension set comprising amedical tube with a spin nut at one end can be connected to thecatheter, so that the free end of the extension set can be attached toanother medical line or system as desired, at a location further awayfrom the insertion site than the catheter hub.

It is often advantageous to restrict the movement of the catheter. Amoving catheter may cause discomfort to the patient, restrict theadministering of fluids or medications or the draining of fluids, causeinfection, or become dislodged from the patient unintentionally. Inorder to keep the catheter or other medical tubing properly positionedfor the duration of treatment, the catheter or medical tubing can bestabilized on the patient in a variety of Ways. Most commonly, themedical provider may attempt to restrict movement of the catheter bysecuring the distal end of the catheter, or a portion of a medicaldevice connected to the catheter such as a connector fitting, to thepatient using tape. Medical providers commonly place long pieces of tapeacross the distal end of the catheter, often in a crisscross pattern, tosecure the catheter distal end to the patient. This securement isintended to inhibit disconnection between the catheter and the patientor between the catheter and another medical article, such as a drainagetube, as Well as to prevent the catheter from catching on other objects,such as on a bed rail.

SUMMARY OF THE INVENTION

The devices, systems, and methods of the present invention have severalfeatures, no single one of which is solely responsible for its desirableattributes. Without limiting the scope of this invention as expressed bythe claims which follow, its more prominent features will now bediscussed briefly. After considering this discussion, and particularlyafter reading the section entitled “Detailed Description of CertainEmbodiments,” one will understand how the features of this inventionprovide several advantages over other medical articles.

One aspect of the present invention is a medical article for use inproviding access to a patient's vasculature. The medical articleincludes an elongated body and a pair of wings extending away from theelongated body. The elongated body has a longitudinal axis, a distalend, and a proximal end. At least one of the pair of wings is configuredto rotate about the longitudinal axis of the elongated body between atleast a first configuration and a second configuration.

Another aspect of the present invention is a medical article for use inproviding access to a patient's vasculature. The medical articleincludes an elongated body, a housing, and a wing extending away fromthe elongated body. The elongated body has a longitudinal axis, a distalend, and a proximal end. The housing is disposed around at least aportion of the elongated body and defines a channel between the housingand the elongated body. The wing is configured to rotate about thelongitudinal axis of the elongated body between at least a firstconfiguration and a second configuration with at least a portion of thewing disposed within the channel.

Yet another aspect of the present invention is a method for introducinga medical line into a patient's vasculature. The method includesproviding a handpiece including a slot and providing a medical articleincluding an elongated body, a pair of wings extending from theelongated body, and a catheter. The elongated body has a longitudinalaxis, a distal end, and a proximal end. Each wing is rotatable about thelongitudinal axis of the elongated body between at least a firstconfiguration and a second configuration and the catheter extends fromthe elongated body in a direction substantially parallel to thelongitudinal axis of the elongated body. The method also includespositioning at least a portion of each of the wings within the slot ofthe handpiece to inhibit free rotation of the wings from the firstconfiguration towards the second configuration.

Another aspect of the present invention is a medical article for use inproviding access to a patient's vasculature. The medical articleincludes an elongated body having a longitudinal axis and a pair ofwings extending from the elongated body. The wings are releasablyattachable to one another and configured to independently rotate aboutthe longitudinal axis of the elongated body between at least a firstconfiguration and a second configuration upon detachment of the wingsfrom one another.

BRIEF DESCRIPTION OF THE DRAWINGS

The above mentioned and other features of the invention will now bedescribed with reference to the drawings of several embodiments of thepresent stabilization system. The illustrated embodiments of thestabilization system are intended to illustrate, but not to limit theinvention. The drawings contain the following figures:

FIG. 1 is a perspective view of a medical article according to apreferred embodiment of the present invention. The medical article ispartially inserted into a handpiece.

FIG. 2 is a perspective view of the medical article and handpiece ofFIG. 1 with the medical article disengaged from the handpiece.

FIG. 3 is a perspective view of the medical article of FIG. 1 with thewings shown in a down configuration.

FIG. 4 is a top plan view of the medical article of FIG. 3.

FIG. 5 is a front view of the medical article of FIG. 3 with the wingsshown in an up configuration.

FIG. 6 is a front view of the medical article of FIG. 3 with the wingsshown in the down configuration.

FIG. 7 is a close-up view of the elongated body and wings shown in FIG.5.

FIG. 8 is a close-up view of the elongated body and wings shown in FIG.6.

FIG. 9 is a bottom view of the medical article of FIG. 3 with the wingspositioned in the up configuration.

FIG. 10 is a bottom view of the medical article of FIG. 3 with the wingspositioned in the down configuration.

FIG. 11 is a close-up view of the elongated body and a wing shown inFIG. 9.

FIG. 12 is a perspective view of the medical article of FIG. 3 shownwith the catheter portion inserted into a patient and secured to thepatient's skin with adhesive strips.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

The following description and the accompanying figures, which describeand show the preferred embodiments, are made to demonstrate severalpossible configurations that a medical article can take to includevarious aspects and features of the invention. Some of the illustratedembodiments are shown with a handpiece that can be utilized by a healthcare provider to insert a medical article (e.g., a catheter) into apatient to provide access to the patient's vasculature. The illustrationof the medical article in this context is not intended to limit thedisclosed aspects and features of the invention to the specifiedembodiments or to usage only with the illustrated handpiece. Those ofskill in the art will recognize that the disclosed aspects and featuresof the invention are not limited to any particular application.

To assist with the description of the components of the medical article,the following coordinate terms are used (see FIG. 1). A “longitudinalaxis” is generally parallel to a portion of the catheter hub or medicalarticle body, as well as parallel to the axis of the catheter. A“lateral axis” is normal to the longitudinal axis. A “transverse axis”extends normal to both the longitudinal and lateral axes. In addition,as used herein, “the longitudinal direction” refers to a directionsubstantially parallel to the longitudinal axis; “the lateral direction”refers to a direction substantially parallel to the lateral axis; and“the transverse direction” refers to a direction substantially parallelto the transverse axis. Also, the terms “proximal” and “distal”, whichare used to describe the present medical article, are used consistentlywith the description of the exemplary applications (e.g., theillustrative examples of the use applications). Thus, proximal anddistal are used in reference to the center of the patient's body. Theterms “upper,” “lower,” “top,” “bottom,” “underside,” “upperside” andthe like, which also are used to describe the present medical article,are used in reference to the illustrated orientation of the embodiment.For example, the term “upperside” is used to describe the portion of themedical article that is located above a lateral axis that passes throughthe longitudinal axis of the medical article. The term “underside” isused to describe the portion of the medical article that is locatedbelow a lateral axis that passes through the longitudinal axis of themedical article. Brief introductions to some of the features, which arecommon to the described embodiments of the medical articles, are nowdescribed.

The preferred embodiments of the present invention advantageouslyprovide a medical article for providing access to a patient'svasculature. The medical article preferably has one or more wingsconfigured to stabilize and/or secure the medical article relative tothe patient's skin. The one or more wings of the medical article can beconfigured to rotate about the longitudinal axis of the medical articlebetween at least a first configuration and a second configuration. Theone or more wings can be configured to lock in place, relative to thebody of the medical article, in one or more configurations. The wingscan also be secured relative to the patient's skin to secure the medicalarticle relative to the patient.

In each of the embodiments described below, the medical article has anelongated body. The elongated body includes a proximal end and a distalend with a catheter extending from the proximal end for insertion into apatient. A fitting can be positioned near the distal end to fluidlycouple the elongated body to a medical line or an extension set. Ahousing can surround the elongated body and create a channeltherebetween through which the pair of wings can move between at least afirst configuration and a second configuration. In some embodiments, thewings and elongated body are joined by a living hinge that allows thewings to bend or rotate relative to the elongated body.

To facilitate a complete understanding of the illustrated embodiment,the remainder of the detailed description describes the medical articlewith reference to the attached figures, wherein like elements among theembodiments are referenced with like numerals throughout the followingdescription.

Medical Article

FIG. 1 shows a perspective view of a medical article 100 partiallyinserted into a handpiece or catheter introducer 200. The medicalarticle 100 includes an elongated body or hub 102, a catheter 108extending from the elongated body 102 in a direction substantiallyparallel to the longitudinal axis of the medical article 100, and a pairof wings 106 a, 106 b extending in an outward direction from the hub102. Wings 106 a, 106 b are shown extending generally parallel to thetransverse axis of the medical article 100 and can be considered in an“up” configuration. When in the up configuration the wings 106 a, 106 bcan be releasably attached to one another. Upon detachment from oneanother, the wings, 106 a, 106 b can rotate independently from oneanother relative to the longitudinal axis of the medical article 100between at least the up configuration and a “down” configuration (seeFIGS. 5 and 6). Alternatively, the wings 106 a, 106 b can be coupled orlinked to one another such that rotation of one of the wings causes theother wing to rotate relative to the longitudinal axis of the medicalarticle.

As shown in FIG. 2, the medical article 100 also includes a fitting 110disposed near the distal end of the elongated body 102. The fitting 110can comprise a luer connector or another fitting configured to connectthe medical article 100 with a variety of other medical articlesincluding medical lines, extension sets, other connector fittings, andthe like. The medical article 100 can also include a one-way valve,membrane, or septum disposed within the elongated body 102. In someembodiments the one-way valve is disposed near the distal end of themedical article 100 or fitting 110 to permit the passage of fluidtherethrough in a single direction, for example, into a patient.

The distal end of the medical article 100 can be partially inserted intohandpiece 200 such that at least a portion of the wings 106 a, 106 b ofthe medical article abut the handpiece 200. The handpiece 200 caninclude a slot 202 configured to receive a portion of the wings 106 a,106 b to inhibit or limit free rotation of the wings when they arepartially received within the slot 202. The handpiece 200 can alsoinclude one or more contoured surfaces 204 a, 204 b to facilitate propergripping of the handpiece 200. By such a configuration, the handpiece200 and the elongated body 102 can cooperate to assist a medicalprofessional in handling and placing the catheter 108 in a patient'svasculature.

As shown in FIGS. 3-11, the wings 106 a, 106 b can rotate relative tothe elongated body 102 from the up configuration to the downconfiguration. FIGS. 3 and 4 show the wings 106 a, 106 b in the downconfiguration. The wings 106 a, 106 b can be configured to stabilize themedical article 100 on a patient when they are in the downconfiguration. The wings 106 a, 106 b can further be configured tosecure the medical article relative to the patient. In some embodiments,the wings 106 a, 106 b can include an adhesive layer disposed over aportion of each wing to secure the wings to the patient. As discussed inmore detail below, in other embodiments, the wings 106 a, 106 b can betaped to a patient to inhibit movement of the medical article 100relative to the patient. When the wings 106 a, 106 b are secured to apatient, they can act to inhibit longitudinal, lateral, transverse, androtational movement of the elongated body 102 relative to the patient.

The wings 106 a, 106 b can comprise various suitable materialsincluding, for example, plastics or textiles. In some embodiments, thewings 106 a, 106 b can be biased to rotate away from one another upondetachment of the wings from one another. For example, the wings 106 a,106 b can be spring-loaded to rotate relative to the longitudinal axisof the medical article 100. In some embodiments, the wings 106 a, 106 bcan be joined with the medical article 100 by a living hinge that isconfigured to allow the wings to bend or rotate along the line of thehinge. In other embodiments, the wings 106 a, 106 b can be unbiased andmanually rotatable (independently or together) relative to the medicalarticle 100 by a medical professional. As shown in FIG. 4, the wings 106a, 106 b can optionally include tabs 150 a, 150 b that a medicalprofessional can use to separate the wings from one another and furthermanipulate the wings relative to the longitudinal axis of the elongatedbody 102.

The wings 106 a, 106 b can each form an angle of between about 0 degreesand about 30 degrees with the skin of the patient when they are in thedown configuration. For example, the wings 106 a, 106 b can each form anangle of between about 5 degrees and about 10 degrees with the skin ofthe patient. This configuration can result in an offset of the elongatedbody 102 from a portion of the patient. The wings 106 a, 106 b can alsobe configured to stabilize the medical article 100 relative to thepatient such that the longitudinal axis of the medical article 100 andthe skin of the patient form an angle between about 5 degrees and about35 degrees. This angle can facilitate a proper insertion of the catheter108 into the patient's vasculature.

The needle of the catheter 108 includes a beveled tip. Preferably thebevel is aligned with one or more points on the medical article. Forexample, the bevel can be aligned with a 12 o'clock position of theelongated body 102 and/or housing 302. In some embodiments, the beveland the wings 106 a, 106 b can be rotationally aligned about thelongitudinal axis of the medical article 100. As illustrated in FIG. 1,the bevel can be aligned with the wings 106 a, 106 b in the upconfiguration. Aligning the bevel relative to the medical article canfacilitate the proper placement of the bevel within a patient'svasculature.

As can be seen most clearly in FIGS. 5-8, in some embodiments, a housing302 can be disposed around a portion of the elongated body 102 to form achannel between the housing and the elongated body. The housing 302 andwings 106 a, 106 b can include interengaging structure which whenengaged limits or inhibits further rotation of the wings 106 a, 106 brelative to the body 102. For example, the housing 302 can include oneor more detents 704 a, 704 b configured to receive protrusions 702 a,702 b disposed on the wings 106 a, 106 b. Of course the housing 302 mayinclude the protrusions 702 a, 702 b and the wings 106 a, 106 b mayinclude the detents 704 a, 704 b.

The detents 704 a, 704 b and the protrusions 702 a, 702 b can beconfigured to releasably lock the wings 106 a, 106 b relative to theelongated body 102 when the protrusions are slid over and receivedwithin the detents. The detents 704 a, 704 b can act to limit therotation of the wings 106 a, 106 b and/or to define a configuration forthe wings, for example, the down configuration. In some embodiments, thewings 106 a, 106 b can be releasably locked relative to the elongatedbody 102 in the down configuration.

FIGS. 9-11 show bottom views of the medical article 100. In FIG. 9, thebottom of the medical article 100 is shown with the wings 106 a, 106 bpositioned in the up configuration. The protrusions 702 a, 702 b arepositioned outside the housing 302 and are offset from the detents 704a, 704 b. FIG. 10 shows the wings 106 a, 106 b in the down configurationwith the protrusions 702 a, 702 b received within the detents 704 a, 704b to releasably lock the wings relative to the elongated body 102 in thedown position.

FIG. 11 shows a close-up view of the elongated body 102, housing 302,and wing 106 b shown in FIG. 9. The housing 302 can include a lip 1102and the wing 106 b can include a hook 1104 that is positioned betweenthe housing 302 and the elongated body 102. The hook 1104 can movearound the elongated body 102 as the wings 106 a, 106 b rotate relativeto the longitudinal axis of the medical article. For example, the hookcan engage the lip 1102 of the housing 302 as the hook 1104 can move ina channel or space 1107 between the housing 302 and the elongated body102. FIG. 11 also illustrates an exemplary wall thickness 1106 of thehousing 302.

Method of Use

The following method of use will be with reference principally to FIGS.1, 2, and 12 and will be in the context of starting an intravenous(“I.V.”) line using medical article 100 and handpiece 200. Thediscussion of one embodiment of a method of use is meant to augment thedescription of the invention above and both should be read together.

In starting an I.V. line, the medical professional begins by insertingthe medical article 100 into the handpiece 200 as shown in FIG. 1. Themedical professional then uses the medical article 100 and handpiece 200to insert the catheter 108 into the vasculature of the patient 1201 withthe beveled tip positioned up. The medical professional can then removethe medical article 100 from the handpiece 200 and discard thehandpiece. The medical professional can then attach a connector 1210 tothe fitting 110 to establish fluid communication between the medicalarticle 100 and a medical line 1212.

Once the catheter 108 is inserted into the patient 1201 and the medicalarticle 100 is connected to a medical line 1212, the medicalprofessional can move the wings 106 a, 106 b to the down configuration.As discussed above, in some embodiments, the wings 106 a, 106 b canoptionally be releasably locked relative to the elongated body 102. Themedical professional can then secure the medical article 100 to thepatient 1201 by placing adhesive strips 1203 over the wings 106 a, 106 band/or by adhering the wings 106 a, 106 b directly to the patient'sskin.

Finally, the medical professional can position a dressing or covering1205, for example, a piece of Tegaderm™, over the insertion site toprotect the site from infection. The covering 1205 can be providedseparate from the medical article 100 or the covering 1205 can beintegral with the medical article 100. For example, the covering 1205can initially be disposed at least partially between the wings 106 a,106 b when they are in the up configuration such that the covering 1205is released as the wings are moved to the down configuration. In oneembodiment, the covering 1205 is folded between the wings 106 a, 106 bin the up configuration such that the covering unfolds in the proximaldirection when the wings 106 a, 106 b are moved to the downconfiguration. For example, the covering 1205 can be folded multipletimes in an accordion or fan-like arrangement between the wings 106 a,106 b such that the covering unfolds when the wings 106 a, 106 b aremoved apart from one another.

The covering 1205 and the wings 106 a, 106 b can be formed as anintegral, single piece. Alternatively, the covering 1205 and the wings106 a, 106 b are formed separately and then attached together. In thiscase, the covering 1205 and the wings 106 a, 106 b may be attached byany means or mechanism that allows the covering 1205 to fold, bend, orrotate down over the insertion site area. Attachment means include glueor adhesive, a weld of the materials, heat sealing, mechanical fastenerssuch as staples or eyelets, or other such means of attachment.

The occlusive covering 1205 can be configured to be waterproof orotherwise impermeable to liquids and in some embodiments also restrictsthe flow of air. In other embodiments, the covering 1205 may beconfigured to be breathable, allowing air and/or moisture near aninsertion site through to the other side of the covering 1205 and awayfrom the insertion site, while keeping at least external moisture on theother side of the covering 1205 away from the insertion site. In someembodiments, the covering 1205 is impermeable to viruses and bacteria,and may comprise or be coated with an anti-bacterial or anti-microbialmaterial. In some embodiments, the covering 1205 comprises or is coatedwith a waxy material. In some embodiments, the covering 1205 comprises afilm which may or may not be transparent. Selection of a transparentfilm for use as the covering 1205 may allow a medical provider to seethe insertion site and any administered catheter. In some embodiments,covering 1205 is absorbent.

The wings 106 a, 106 b can be used as a long-term solution to secure themedical article 100 relative to the patient 1201 until the catheter 108is removed. Alternatively, the wings 106 a, 106 b can be used as ashort-term or temporary solution to secure the medical article 100relative to the patient 1201 until the medical article is securedrelative to the patient by a different device or method.

The various embodiments of medical articles and techniques describedabove thus provide a number of ways to stabilize a medical article tothe skin of a patient. In addition, the techniques described may bebroadly applied for use with a variety of medical lines and medicalprocedures.

Of course, it is to be understood that not necessarily all suchobjectives or advantages may be achieved in accordance with anyparticular embodiment using the systems described herein. Thus, forexample, those skilled in the art will recognize that the systems may bedeveloped in a manner that achieves or optimizes one advantage or groupof advantages as taught herein without necessarily achieving otherobjectives or advantages as may be taught or suggested herein.

Furthermore, the skilled artisan will recognize the interchangeabilityof various features from different embodiments. Although thesetechniques and systems have been disclosed in the context of certainembodiments and examples, it will be understood by those skilled in theart that these techniques and systems may be extended beyond thespecifically disclosed embodiments to other embodiments and/or uses andobvious modifications and equivalents thereof. Additionally, it iscontemplated that various aspects and features of the inventiondescribed can be practiced separately, combined together, or substitutedfor one another, and that a variety of combination and subcombinationsof the features and aspects can be made and still fall within the scopeof the invention. Thus, it is intended that the scope of the systemsdisclosed herein disclosed should not be limited by the particulardisclosed embodiments described above but by a fair reading of theclaims which follow.

What is claimed is:
 1. A medical device assembly, comprising: acatheter, including a catheter hub; a housing surrounding the catheterhub, the housing spaced from the catheter hub such that a channel isdefined therebetween; a first wing having a first hook disposed in thechannel to permit rotation of the first wing about the catheter hub, thefirst wing extending from the catheter hub in a first direction; and asecond wing having a second hook disposed in the channel to permitrotation of the second wing about the catheter hub, the second wingextending from the catheter hub in a second direction opposite the firstdirection.
 2. The medical device assembly according to claim 1, whereinthe catheter includes a bevel rotationally aligned with the first wingwhen the first wing is in an insertion position.
 3. The medical deviceassembly according to claim 1, further comprising an adhesive layerdisposed on each of the first wing and the second wing.
 4. The medicaldevice assembly according to claim 1, wherein the catheter hub comprisesa luer connector configured to connect the catheter hub with a medicalline.
 5. The medical device assembly according to claim 1, wherein thefirst wing is designed to rotate independently from the second wing. 6.The medical device assembly according to claim 1, wherein the first wingand the second wing are connected such that rotation of the first wingsimultaneously rotates the second wing.
 7. The medical device assemblyaccording to claim 1, wherein the first wing and the second wing arespring-loaded to bias rotation of the first wing away from the secondwing.
 8. The medical device assembly according to claim 1, furthercomprising a handpiece including a slot, wherein at least a portion ofthe first wing is received within the slot when the first wing is in aninsertion position.
 9. The medical device assembly according to claim 8,wherein the slot inhibits free rotation of the first wing out of theinsertion position.
 10. The medical device assembly according to claim8, wherein an end of the catheter hub is received within the slot. 11.The medical device assembly according to claim 1, wherein at least oneof the first wing and the second wing includes a protrusion.
 12. Themedical device assembly according to claim 11, wherein the housingincludes at least one detent configured to engage with the protrusion.13. The medical device assembly according to claim 1, wherein a radiallyouter portion of the first wing is releasably attached to a radiallyouter portion of the second wing in an insertion position.
 14. Themedical device assembly according to claim 13, wherein the radiallyouter portions of the first wing and the second wing are designed to bedetached following insertion of the catheter into a patient and rotatedaway from one another toward the patient.
 15. The medical deviceassembly according to claim 14, further comprising an adhesive layerdisposed on each of the first wing and the second wing, the adhesivelayer designed to adhere to the patient.